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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Manual
510(k) Number K944522
Device Name MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
Applicant
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received09/16/1994
Decision Date 02/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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